RECRUITING

Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention

Conditions

Cocaine Use Disorder Cocaine Use Cocaine Addiction Cognitive Behavioral Therapy Relapse Prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine.

Official Title

Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention

Quick Facts

Study Start:2021-08-23

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04843046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18 to 65 years old * meet DSM 5 diagnostic criteria for cocaine use disorder * report recent cocaine use, verified by at least one positive urine drug screen for the cocaine metabolite, benzoylecgonine, during intake * be judged by the medical staff to be psychiatrically stable and physically healthy * for females, be using an effective form of birth control (e.g., barrier, IUD, or sterilization) and not be pregnant as determined by a serum pregnancy test at screening and negative urine pregnancy test at intake prior to first dose of investigational drug (test will be repeated weekly to ensure that female patients do not continue in the study if pregnant) or lactating * be willing to be admitted to a 5-day inpatient detoxification program at The Right Step Houston * be able to understand the consent form and provide written informed consent * be able to provide the names of at least 2 persons who can consistently locate their whereabouts	* have an acute medical or psychiatric disorder that would, in the judgment of the study physician, make participation difficult or unsafe * have suicidal or homicidal ideation that requires immediate attention * have another current (≥ moderate) substance use disorder aside from alcohol, nicotine, or marijuana * have a medical condition contraindicating PIO pharmacotherapy (e.g., drug- or insulin-dependent diabetes, congestive heart failure, edema, clinical significant liver disease, hypoglycemia, history of bladder cancer) or be taking medications that would adversely interact with PIO (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications) * be concurrently enrolled in other addiction treatment services aside from smoking cessation * if female, be currently pregnant, breastfeeding, or planning on conception * have conditions of probation or parole requiring reports of drug use to officers of the court * be unable to read, write, or speak English * be homeless (live on the street) * have medical contraindications to MRI/DTI scans (e.g., history of pacemaker, metal implants, or welding/metal work without protective eyewear)

Inclusion Criteria

Exclusion Criteria

* 18 to 65 years old
* meet DSM 5 diagnostic criteria for cocaine use disorder
* report recent cocaine use, verified by at least one positive urine drug screen for the cocaine metabolite, benzoylecgonine, during intake
* be judged by the medical staff to be psychiatrically stable and physically healthy
* for females, be using an effective form of birth control (e.g., barrier, IUD, or sterilization) and not be pregnant as determined by a serum pregnancy test at screening and negative urine pregnancy test at intake prior to first dose of investigational drug (test will be repeated weekly to ensure that female patients do not continue in the study if pregnant) or lactating
* be willing to be admitted to a 5-day inpatient detoxification program at The Right Step Houston
* be able to understand the consent form and provide written informed consent
* be able to provide the names of at least 2 persons who can consistently locate their whereabouts

* have an acute medical or psychiatric disorder that would, in the judgment of the study physician, make participation difficult or unsafe
* have suicidal or homicidal ideation that requires immediate attention
* have another current (≥ moderate) substance use disorder aside from alcohol, nicotine, or marijuana
* have a medical condition contraindicating PIO pharmacotherapy (e.g., drug- or insulin-dependent diabetes, congestive heart failure, edema, clinical significant liver disease, hypoglycemia, history of bladder cancer) or be taking medications that would adversely interact with PIO (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications)
* be concurrently enrolled in other addiction treatment services aside from smoking cessation
* if female, be currently pregnant, breastfeeding, or planning on conception
* have conditions of probation or parole requiring reports of drug use to officers of the court
* be unable to read, write, or speak English
* be homeless (live on the street)
* have medical contraindications to MRI/DTI scans (e.g., history of pacemaker, metal implants, or welding/metal work without protective eyewear)

Contacts and Locations

Study Contact

Joy M Schmitz, PhD

CONTACT

713-486-2867

Joy.M.Schmitz@uth.tmc.edu

Jessica N Vincent, BS

CONTACT

713-486-2803

Jessica.N.Vincent@uth.tmc.edu

Principal Investigator

Joy M Schmitz, PhD

PRINCIPAL_INVESTIGATOR

UT Houston

Scott D Lane, PhD

PRINCIPAL_INVESTIGATOR

UT Houston

Study Locations (Sites)

UTHealth Center for Neurobehavioral Research on Addiction

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Joy M Schmitz, PhD, PRINCIPAL_INVESTIGATOR, UT Houston
Scott D Lane, PhD, PRINCIPAL_INVESTIGATOR, UT Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-23

Study Completion Date2025-08

Study Record Updates

Study Start Date2021-08-23

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

Cocaine Use
Cocaine Addiction
Cognitive Behavioral Therapy
Relapse Prevention

Additional Relevant MeSH Terms

Cocaine Use Disorder